Fujirebio Diagnostics Receives FDA Breakthrough Device Designation for Lumipulse® G β-Amyloid Ratio (1-42/1-40) Quantitative In Vitro Diagnostic Test

MALVERN, Pa.–(BUSINESS WIRE)–Fujirebio Diagnostics, Inc., a consolidated subsidiary of Miraca
Holdings Inc., has received Breakthrough Device Designation (formerly
known as Expedited Access Pathway (EAP) designation) from the Center of
Devices and Radiological Health (CDRH) of the U.S. Food and Drug
Administration (FDA) on January 3, 2019 for the Lumipulse G β-Amyloid
Ratio (1-42/1-40) quantitative in vitro diagnostic test. The
Breakthrough Devices Program is designed to expedite the development and
review of certain medical devices that provide for more effective
treatment or diagnosis of a life-threatening or irreversibly
debilitating disease or condition.

“We are very pleased that the FDA has granted us breakthrough status for
this important new diagnostic tool in the fight against Alzheimer’s
Disease,” said Monte Wiltse, President and CEO of Fujirebio Diagnostics,
Inc. “The entire Fujirebio group of companies are committed to bringing
novel diagnostic tools for Alzheimer’s Disease to healthcare systems
globally, and we look forward to working closely with the FDA to provide
both physicians and patients this innovative, new test.”

The Lumipulse G β-Amyloid Ratio (1-42/1-40) is a quantitative in vitro
diagnostic test using measurable β-Amyloid 1-42 and β-Amyloid 1-40
concentrations found in human cerebral spinal fluid (CSF) and combines
those concentrations into a numerical ratio of β-Amyloid 1-42/ β-Amyloid
1-40 to estimate the presence of β-Amyloid neuritic plaque pathology in
the brain.

The Lumipulse G β-Amyloid Ratio (1-42/1-40) combines the results of
Lumipulse G β-Amyloid 1-42 and β-Amyloid 1-40 using the Lumipulse G
System. The Lumipulse G β-Amyloid Ratio (1-42/1-40) results are intended
to aid in the assessment of adult patients, aged 50 years and over,
presenting with cognitive impairment who are being evaluated for
Alzheimer’s Disease (AD) and other causes of cognitive decline. The
Lumipulse G β-Amyloid Ratio (1-42/1-40) results must be interpreted in
conjunction with other diagnostic tools such as neurological
examination, neurobehavioral tests, imaging and routine laboratory tests.

A negative Lumipulse G β-Amyloid Ratio (1-42/1-40) result is consistent
with a negative amyloid PET scan result. A positive Lumipulse G
β-Amyloid Ratio (1-42/1-40) result is consistent with a positive amyloid
PET scan result. A positive result does not establish a diagnosis of AD
or other cognitive disorder. This test is not intended as a screening or
stand-alone diagnostic assay. Fujirebio Diagnostics, Inc., looks forward
to providing a commercially available in vitro diagnostic test to help
in the assessment of Alzheimer’s Disease; a disease with 5.7 million
afflicted Americans resulting in the sixth leading cause of death in the
United States (ww.alz.org).

About Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics is a global leader in the field of high quality in
vitro diagnostics (IVD) testing. It has more than 40 years’ accumulated
experience in the conception, development, production and worldwide
commercialization of robust IVD products. Fujirebio Diagnostics has a
strong and long-lasting tradition of collaborating with experts in the
worldwide clinical community in the development of high-quality routine
and truly novel biomarkers that cover a variety of disease states. Its
IVD product lines span the range from specialized manual and automated
testing to fully automated routine clinical laboratory testing
solutions. For more information about Fujirebio Diagnostics, please call
+1 610-240-3800 or visit us as www.fujirebio-us.com.

Fujirebio Diagnostics is today a member of Miraca Group (Miraca Holdings
Inc. listed on the Tokyo Stock Exchange – TYO: 4544).


Hiroshi Sekiya
Fujirebio US, Inc.

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